VOL I - LQM-Policy -v1.7

8/2/2019 VOL I - LQM-Policy -v1.7

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This document is uncontrolled when printed: 2/11/2010

For the most current and official copy, check the Intranet at

http://web.ora.fda.gov/dfs/policies/manuals/default.htm

VOLUME I

LABORATORY MANUALOf

Quality Policies

FOR

ORA Regulatory Laboratories

Division of Field ScienceOffice of Regulatory Affairs

Food and Drug Administration


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2

TABLE OF CONTENTS

Section Topic Page

1.0 Introduction 3

2.0 Controlled Distribution of the Quality Manual 3

3.0 Quality Policy Statement 3

4.0 Management Requirements 3

4.1 Organization 3

4.2 Management System 64.3 Document Control 11

4.4 Review of Requests, Tenders and Contracts 13

4.5 Subcontracting of Tests 14

4.6 Purchasing Services and Supplies 154.7 Service to the Customer 17

4.8 Complaints 17

4.9 Control of Non-conforming Work 174.10 Improvement 18

4.11 Corrective Action 18

4.12 Preventive Action 204.13 Control of Records 20

4.14 Internal Audits 22

4.15 Management Reviews 23

5.0 Technical Requirements 24

5.1 General 245.2 Personnel 25

5.3 Accommodation and Environmental Conditions 27

5.4 Test Methods and Method Validation 295.5 Equipment 33

5.6 Measurement Traceability 36

5.7 Sampling Operations 39

5.8 Handling of Samples 405.9 Assuring the Quality of Test Results 41

5.10 Reporting the Results 42

Document /Change History 44


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ORA-LAB.QMPAGE 3 OF 46

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ORA LABORATORY MANUAL OF QUALITY POLICIESEFFECTIVE DATE:

10-01-03

REVISED:01-26-10


For the most current and official copy, check the Internet athttp://www.fda.gov/ScienceResearch/FieldScience/default.htm

1.0 Introduction

This Office of Regulatory Affairs (ORA) Laboratory Manual of Quality Policies (hereafter

referred to as Volume I) has been prepared to meet the requirements for laboratory accreditationof the International Organization for Standardization/International Electrotechnical Commission

(ISO/IEC) 17025 (2005). It has been formatted using clause numbers from ISO/IEC 17025 to

provide ease in review.

2.0 Controlled Distribution of the Quality Manual

The Division of Field Science (DFS) is responsible for maintaining the official master copy of

the ORA Laboratory Manual which contains the ORA Quality Manual. The ORA Quality

Manual consists of Volume I, ORA Laboratory Manual of Quality Policies and Volume II, ISO17025 ORA Laboratory Procedures. General distribution of this manual is accomplished using a

computer network. Annual review is coordinated by the Division of Field Science.

3.0 Quality Policy Statement

ORA laboratories are committed to laboratory accreditation according to the requirements ofISO/IEC 17025. This commitment is evidenced by the approval signatures for this manual.

The quality policy statement is stated in Volume I, Subsection 4.2.2

4.0 Management Requirements

4.1 Organization

I. Principal Responsibilities

The Associate Commissioner for Regulatory Affairs (ACRA) is responsible for establishing the

organizations commitment to the management system, implementing it, and delegating

responsibility for its accomplishment.

The Director of the Division of Field Science is responsible for issuing policy and procedures forthe ORA laboratories and monitoring their implementation.

Laboratory management, including supervisory analysts and quality managers, is responsible for

ensuring that analytical activities meet the requirements of the agency, its customers, and


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regulations in 21 Code of Federal Regulations (CFR), 29 CFR, Part 1910.1450, 40 CFR, Parts

260-264, 49 CFR, Parts 171-173 and the Food, Drug and Cosmetic (FD&C) Act. In addition,

each person involved in the generation of data is part of the management system.

II. Policies

4.1.1 The Food and Drug Administration (FDA) is a government agency under the Departmentof Health and Human Services (HHS). The agency is required to follow the federal

regulations in 21 CFR, 29 CFR, 40 CFR, 49 CFR, the FD&C Act and PHS Act.

4.1.2 The intent of ORA is to operate testing laboratories according to the followingrequirements:

FDA policies and procedures,

ISO/IEC 17025,

customer contracts (workplan),

ORA compliance programs and assignments,

Federal and State laws and regulations, and

American Association of Laboratory Accreditation (A2LA) Accreditation

Criteria.

4.1.3 ORA laboratories operate permanent facilities in five regions across the United States andPuerto Rico at the addresses identified in the Staff Manual Guide (SMG), Section 1300.ORA may operate mobile laboratories as extensions to specified fixed laboratory sites.

4.1.4 The regulatory laboratories are a part of the Office of Regulatory Affairs, FDA and areidentified in the SMG, Section 1300. The organizational charts are foundat www.fda.gov

and www.dhhs.gov. Each laboratory also maintains an organizational chart or charts. Key

personnel are identified in these charts.

4.1.5 a. The laboratory has managerial staff with the authority to discharge their duties asreflected in the prepared job descriptions by the laboratory. This authority includes

the implementation, maintenance, and improvement of the management system.Management authorities are defined in government classification standards found inthe Qualification Standards Operating Manual for General Schedule Positions, U.S.

Office of Personnel Management. The resources needed to discharge these duties are

identified in Volume I Section 5.2to Section 5.6. The identification of departures

from the management system and testing requirementsis documented according tothe laboratorys corrective action procedure.


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4.1.5 b. A Financial Disclosure form OGE 450 is completed annually by employees toprevent participation in any financial matter that might adversely affect the integrity

of their work. Form HHS 520, Approval of Outside Activity, is completed andapproved for employees seeking outside employment.

4.1.5 c. Reports of information and data are transmitted and filed in accordance with officialpolicies, directives, and notices of the department and the agency. Reports and data

are not released until reviewed and verified. The majority of reports are sent to

internal customers only, except as required by law or regulation. Information isreleased only to the customer or designated representative. Field Management

Directive (FMD) No. 147, Procedure for Release of Analytical Results Pursuant toSection 704 (d), provides guidance for reporting analytical results to an externalcustomer. Additionally, FDA facilities are controlled-access buildings to further

ensure protection of data.

4.1.5 d. To avoid conflicts of interest, pressures, and influences, FDA employees are familiarwith and observe the Standards of Ethical Conduct. These principles of ethics can be

found at http://inside.fda.gov:9003/EmployeeResources/Ethics/FDAEthicsProgram/ucm021493.html .Executive Order 12674, issued in 1989 and modified in 1990 by Executive Order

12731, states fourteen general principles that broadly define the obligations of public

service. Two core concepts are embodied in these principles: (a) Employees shall not

use public office for private gain, (b) and employees shall act impartially and not givepreferential treatment to any private organization or individual. The Office of

Government Ethics (OGE) requiresone hour of ethics training annually. Training is

provided on ethics rules, regulations and integrity in order to help employees avoidplacing themselves in a conflict of interest situation. An employee who performs

laboratorytesting performs and documents a demonstration of competence as

prescribed in Volume I, Subsection 5.2

4.1.5 e. The regulatory laboratories are a part of the Office of Regulatory Affairs, FDA andare identified in SMG, Section 1300. The organization and the relationship among the

laboratory staff is reflected in the laboratorys organizational chart maintained by the

laboratory Quality Management System (QMS) Manager.

4.1.5 f. Job responsibilities for laboratory employees are documented in the managementsystem procedures and operating instructions. Position descriptions are maintained bythe Human Resources Center (HHS).

4.1.5 g. The laboratory employees performing testing have access to consensus standards,instrument manufacturers manuals, and laboratory procedures for reference.


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Demonstration of competence for technical personnel is documented and used as

evidence of desired familiarity with laboratory methods. Supervisors are designated

and trainees do not perform regulatory work until competent as per the laboratorytraining program.

4.1.5 h. The Supervisor is responsible for the technical operations of the laboratory.Resources for training, laboratory methods, measurement traceability, and purchasing

are described in sections of this Volume, and in procedures.

4.1.5 i. The laboratory Quality System Manager (QSM) is responsible for the laboratorys

management system and its implementation. The QSM has direct access to theLaboratory Director, who is responsible for decisions concerning policy and

resources.

4.1.5 j. Qualified laboratory personnel are assigned to serve in the absence of key managerialpersonnel, such as Laboratory Director, Quality System Manager, and Supervisor. For

example, the Supervisor or Deputy Director may serve in the absence of theLaboratory Director; either the Laboratory Director, Deputy Director or Supervisor

may serve in the absence of the QSM; and senior technical personnel may serve in the

absence of Supervisors.

4.1.5 k. Laboratory personnel are aware of their function and contribution in the managementsystem and of its objectives.

4.1.6 Effective communication from management occurs through the use of but not limited tomemos, newsletters, electronic presentations, emails, or verbally to laboratory personnel

regarding the effectiveness of the management system.

Related Procedures

Each ORA laboratory has its own corrective action procedure. A template is provided in

Volume II, Section 1, ORA-LAB.4.11 Corrective Action Procedure.

Each ORA laboratory has its own training procedure. A template is provided in VolumeII, Section 1, ORA-LAB.5.2 Personnel: Training Procedure.

4.2 Management System

4.2.1 The laboratory management system is outlined in the following documents:


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Quality manual,

Written procedures,

Work Instructions,

References, and

Forms and records.

This management system is established to address the requirements in ISO/IEC 17025. Each

entity establishes and maintains a master list of procedures per the procedure for document

control. The quality policy and quality objectives for ORA laboratories are included in Volume1, subsection 4.2.2. The documents listed above are accessible to all personnel and are included

in the laboratorys training program.

4.2.2 Management System Policy

Mission

ORAs mission statement states ORA protects consumers and enhances public health by

maximizing compliance of FDA regulated products and minimizing risk associated with those

products. FDA laboratories are committed to providing testing that meets both the needsof thecustomers and the requirements of ISO/IEC 17025 and to continually improve the effectiveness

of the management system. Testing results are reported within stated limits of accuracy,

precision, and detection limits as described in the methods used for analysis.

Commitments to Quality Issued by Director, Division of Field Science

4.2.2 a. Good Professional Practice and the Quality of Testing

ORA laboratories are committed to the Standards of Ethical Conduct which define the

obligations of public service issued under Executive Order 12674. Testing is conductedaccording to the policies stated in Volume I, subsections 5.4; 5.7. The laboratory

management and personnel are committed to performing quality activities to assure

integrity, accuracy, precision, reliability and timeliness of the data.

4.2.2. b. Standard of Service

The laboratorys standard of service for the testing program is defined by the ISO/IEC

17025 requirements, FDA regulatory needs included as part of the laboratory methods,and the following:


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Established and maintained documented procedures for laboratory operation

based upon consensus methods for testing. Methods are specified or cited inthe compliance program and compendiums, or by the customer. In some

cases, testing and procedures as established by the instrument manufacturer

are used.

Sample handling and management procedures to maintain integrity of both thesamples and the documentation to support the analytical data.

Maintenance of records in such manner that facilitates retrieving them later.Records are maintained in the analyst worksheet packet filed by sample

number. Records may be archived on- or off-site depending on the home

district of the collector. Archival retention periods are stated in thelaboratorys record management procedure.

Employment of qualified and trained personnel to perform the tasks to support

the laboratory objectives. Performance demonstrations by technical personnelconducting laboratory methods are conducted and documented.

Routine maintenance of quality control data to support testing results by

demonstrating that measurement processes are maintained in statistical

control. Accuracy and precision control charts are used to monitorperformance.

Maintenance of an instrument calibration program that provides measurementtraceability to International System of Units (SI) units. This is accomplishedwith the use of national, international, or industry accepted standards of

measurement.

ORA laboratory personnel follow the policies included in this Volume, the processesdescribed in their localoperating procedures, and the processes described in laboratory

methods referenced in this Volume.

Changes to management system documents aremadeaccording to the laboratorydocument control procedure and involve periodic revisions of this Volume as part of theannual management review of the management system.

An internal audit process isused to evaluate the effectiveness of the management system

established for laboratory operations. It is the policy of ORA laboratories to participate in


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interlaboratory proficiency programs as these are announcedand as requested by the

accrediting body.

The sections in this Volume describe elements and reference procedures that outline themanagement system established to accomplish the mission of the laboratory.

Test reports and the communication of information generated by the laboratory are

conducted under the direction of the Laboratory Director.

The operational procedures for the laboratory are listed in its master list, as described in

the laboratorys document controlprocedure.

4.2.2 c. Management System Objectives

The primary objective of the management system established by ORA laboratories is to

assure the accuracy and precision of laboratory results so that they will be reliable,

interpretable, repeatable, and defensible. Data quality objectives are described in theterms of:

accuracy,

precision,

detection and quantitation limits,

timeliness, and

comparability.

The second objective is to establish and maintain national and international recognition

through compatibility with the requirements of relevant standards.

Third, strive to meet or exceed the customers needs and expectations for precision,

accuracy, sensitivity, and specificity.

Fourth, maintain ORA laboratories reputation for quality by fostering continuous

process improvement and problem prevention.

These objectives are taken into account as part of the reviews performed by management.

4.2.2 d. Management System Awareness and Implementation

The management system documents and test methods are included as training elements in

the laboratorys training program addressed in the laboratory training procedure. This


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ensures that staff is familiar with quality documentation and implement the quality

policies and procedures in their work. See template, Volume II, Section 2, ORA-LAB.5.2

Personnel: Training Procedure.

The implementation of the quality policies is evidenced by the manner in which work

activities are conducted. Implementation of the management system procedures is

evidenced by the generation of required records. The audit and management reviewactivities are the mechanisms that are used to monitor the implementation effort of the

laboratory management system.

4.2.2 e. Commitment to ISO/IEC 17025.

The policies for operation of the laboratory management system are established toaddress the requirements of ISO/IEC 17025. ORA laboratories are committed to

laboratory accreditation according to the requirements of ISO/IEC 17025. This

commitment is evident by the approval signatures by each Laboratory Director for thisquality manual.

4.2.3 Evidence of managements commitment to the management system and its continual

improvement in effectiveness is demonstrated by but not limited to participation ofmanagers in the management reviews, performance of internal audits, proficiency testing,

and the analysis of quality control samples.

4.2.4 Effective communication from management occurs through the use of but not limited to

memos, newsletters, electronic presentations, emails, or verbally to laboratory personnel

regarding the importance of meeting customer, statutory, and regulatory requirements.

4.2.5 Procedures and Outline of the Management System

Management system procedures supporting quality policies are cited in the Related Procedures at

the end of each section of this Volume. The outline of the management system is included in

Volume I, Subsection 4.2.1. Where needed, each laboratory shall have procedures to implement

the quality policies at the local level and include these procedures in its Master List.Laboratories shall include a reference to the corresponding requirements in this Volume.

4.2.6 Roles and Responsibilities

General roles and responsibilities for ORA laboratory personnel are summarized as follows:

Quality System Manager Ensures that the management system is established, implemented, and

maintained in conformance with the requirements of ISO/IEC 17025.


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Advocates and coordinates quality improvements to the management

system.

Responsible Managers (technical management)

Oversee technical functions. Ensure compliance with the requirements of ISO/IEC 17025.

Ensure management system procedures, applicable standards, specifications,

and regulations are followed.

Ensure that qualified, skilled, and trained personnel and other resources areavailable.

Ensure that products and services satisfy customer requirements.

Analysts

Ensure the quality of their work. Operate in conformance with the requirements of the management system.

4.2.7 The management system process and procedures as defined in this manual maintain theintegrity of the management system when changes such as a change in the structure of the

organization or management, or a change is a policy or procedure are made.

4.3 Document Control4.3.1 General

The document control and management procedurein each laboratory describes the process for

controlling quality documents that form part of its management system. The quality documents

include those required for the generation of laboratory data. These documents include thosepublished by the laboratory and those published externally. Documents of external origin include

regulations, standards, test methods, instructions and manuals.

4.3.2 Document Approval and Issue

4.3.2.1Documents issued to personnel in the laboratory as part of the management system arereviewed and approved for use prior to issue in accordance with the laboratorys

document controland managementprocedure. The laboratorys master list identifies the

current revision status and distribution of documents in the management system. Throughthe use of the master list, quality documents are postedto personnel to preclude the use of

invalid or obsolete documents.


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4.3.2.2Procedure Content

The laboratorys master listand document control and record managementprocedureprovide for the following:

a. Authorized management system documents and external documents are at locations

where operations essential to the effective functioning of the laboratory areperformed.

b. Documents are reviewed according to a schedule and revised to ensure continuing

suitability and conformance with the management system and ISO/IEC 17025requirements.

c. Invalid or obsolete documents are promptly removed from all points of issue or use,

or marked as Uncontrolledto assure against unintended use.

d. Obsolete documents retained for either legal or knowledge preservation purposes are

suitably marked such asArchivedor Obsolete.

4.3.2.3Document Identification

A document control header as described in the laboratorysdocument control and managementprocedure uniquely identifies management system documents generated by the laboratory. Suchidentification includes the date of revision, identification number and inclusive pagination. The

issuing authority is indicated by the name of the approving official in the document history

section of each document.

4.3.3 Document Changes

Changes to documents are reviewed and approved in accordance with the laboratorys documentcontroland management procedure. Unless designated otherwise, this procedure is followed by

the same personnel or function as in the original review or approval. The use of reference

documents and information is required upon which to base the review and approval.

4.3.3.1 The altered or new text is identified either in the document, document change history

section, on a cover page, or in attachments. Changes can be described in general terms since thedetails can be demonstrated in the archived document.


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4.3.3.2 The laboratorys document controland management procedure addresses the handling of

document amendments by hand pending reissue.

4.3.3.3 Computerized Systems

The laboratorys document controland management procedure addresses the control of

electronic management system documents.

Related Procedures

Each ORA laboratory has its own document control and management procedure. Atemplate is provided in Volume II, Section 1, ORA-LAB.4.3., Document Control andManagement

4.4 Review of Requests, Tenders and Contracts

4.4.1 Review

ORA, Division of Planning, Evaluation and Management (DPEM) develops and issues the

Annual Fiscal Year (FY) Workplan for ORA field units. The portion of the workplan concernedwith the laboratories is a cooperative effort among the Centers, ORA Field Committee, and DFS.

The workplan is based on several factors such as the budget, the number ofanalysts and amount

ofresources, the Commissioners performance goals, the compliance program accomplishment

goals, the inventory of regulated industry maintained by the field units, and FDA-targetedproducts. Distribution of assignments is by Program Assignment Code (PAC) and full time

equivalent (FTE) hours within the different program areas. The compliance programs specify or

cite the methods for analyses. The ORA laboratories and DFS review the annual workplan toensure that each laboratory has the capability and resources to provide the requested services.

Any differences between the workplan and the laboratory capability are resolved in accordance

with FDA Field Management Directive 17B, Management of Compliance Programs by the Fieldor through consultation with District/Regional management.

In addition to the workplan, assignments may be issued to ORA laboratories by an ORA

headquarters unit or a Center. Multiple district assignments and high priority requests for workare approved according to FDA Field Management Directive 17, ORA Field Assignments-

Guidelines for Issuance by Headquarters.Such assignments are cleared through the Office of

Regional Operations (ORO). Assignments specify or cite the methods for analyses.Requests not covered by compliance programs or assignments are reviewed prior to receipt of

samples by the laboratorys management when possible.


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The results of this process are discussed and documented as part of the laboratorys annual

management review.

4.4.2 Records of Review

ORA laboratories maintain records of workplan reviews, changes, and change requests (FMD-17B). Records are also maintained of discussions regarding ad hoc assignments.

4.4.3 Subcontracting Laboratories

The policies regarding the use of subcontracting laboratories are found in Volume I Subsection

4.5 Subcontracting of Tests. The customer requesting collaborative testing by laboratoriesoutside of ORA is responsible for the work done by such labs. ORA is not responsible for such

work under these circumstances.

4.4.4 Contract Deviations

Requests for deviations from workassignments or compliance programs are processed by the

Division of Field Science (DFS). DFS interacts with the customer to determine whether therequested changes are acceptable. Records of contract changes are maintained.

4.4.5 Amendments to Contracts

If a contract needs to be amended after work has commenced, the same contract review process

is repeated and any amendments are communicated to all affected personnel named in thecontract.

Related Documents

FDA Field Management Directive 17B, Management of Compliance Programs by theField

FDA Field Management Directive 17, ORA Field Assignments-Guidelines for Issuanceby Headquarters

Annual Workplan

4.5 Subcontracting of Tests

ORA laboratories do not subcontract routine analyses within their scope of accreditation.


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Collaborative activities conducted with external laboratories, such as universities, are research in

nature and do not involve the routine analysis of FDA samples.

4.5.1 Subcontracting Laboratories

Based on workload fluctuations and resource needs, ORA laboratories may request samples

assigned to other FDA laboratories for analysis. Samples are administratively transferred afterarrangements are made to ensure that the receiving laboratory has the capacity and capability to

complete it in a timely manner.

Samples are shipped according to Department of Transportation (DOT), United States PostOffice (USPS), and carrier regulations. The manual for the Field Accomplishments and

Compliance Tracking System (FACTS) describes the procedure for documentingadministratively transferred samples (ATS).

4.5.2 Notification of Customer

FACTS, which is accessible to the customer, serves as a notice of the transfer.

4.5.3 Laboratory Responsibility

The FDA laboratory to which the sample has been transferred assumes responsibility to thecollector for the work.

Related Procedures

FACTS Manual

4.6 Purchasing Services and Supplies

4.6.1 Procedure

The laboratory or designated purchasing agents use Federal Acquisition Regulations (FAR) andrelated procedures for the procurement of materials, supplies and services that critically affect

the quality of the tests or calibrations. These procedures describe the process for the selection,

purchase, reception and storage of equipment, services and supplies, including reagents andlaboratory consumable materials, used in the performance of the tests and calibrations. Each

laboratory has work instructions describing the processing of requisitions.


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4.6.2 Inspection and Verification

The laboratorys purchasingproceduredescribes how purchased equipment, supplies, services,reagents, and consumable materials that critically affect the quality of tests or calibrations are

inspected or verified prior to use or concurrently with use. Inspection or verification criteria are

used to establish conformance with requestsmadeby the customer, included in standard

specifications, or defined in the methods.

4.6.3 Purchasing Documents

Purchasing documents for items affecting the quality of laboratory output describe the servicesor supplies ordered. These purchasing documents are reviewed and approved for technical

content prior to submission.

4.6.4 Records and Registry

Records of supplier evaluations and a list of approved suppliers are maintained by purchasers of

laboratories equipment, services, and supplies.

Related Procedures

Government Accounting Office (GAO) Policy and Procedures Manual

SMG 2610 Procurement and Supply Management

Federal Acquisition Requirements

Office of Management and Budget (OMB), General Service Administration (GSA),HHS, Federal Property Management Regulations (FPMR), FDA and ORA manuals,

specific issuances

Public Law (PL) 95-507

Each ORA laboratory has its own purchasing procedure. A template is provided. See Volume II,Section I, ORA-LAB4.6 Purchasing Services and Supplies.


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4.7 Service to the Customer

4.7.1 The laboratory affords the requesting customer cooperation to clarify the customer'srequest within the framework of the contract review process described in Volume I,

Section 4.4 Review of Requests, Tenders and Contracts. The laboratory maintains

communications regarding deviations from contract work. Communications regarding

compliance programs, workplan and assignments are conducted through DFS.

The opportunity for the customer to witness laboratory activity is givenupon request,

providing the laboratory is able to maintain confidentiality to other customers during suchcases.

4.7.2 The laboratory seeks customer feedback on their services and general performance.Records of the comments, both positive and negative, are maintained and are taken into

account for identifying management system improvements during the reviews performed

by management.

Related Procedures

None

4.8 Complaints

The laboratory has a complaint procedure describing the process for the receipt and recording ofcomplaints received from any party. Records of all complaints received are maintained according

to the procedure. Complaints identified as nonconformities are processed according to Volume I,

Section 4.11 Corrective Action.

Related Procedures

Each ORA laboratory has its own procedurefor handling complaints. A template is

provided. See Volume II, Section I, ORA-LAB.4.8 Complaints.

4.9 Control of Non-conforming Work

4.9.1 Procedure

The ORA laboratories have a control of non-conforming work procedure that is implemented


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when any aspect of their testing work, or the results of this work, does not conform to

requirements of the management system, testing methods, or the requests of the customer. This

procedure addresses the following elements:

responsibilities and authorities for the management of identified non-conforming workand taking actions such as the halting of work, the withholding of test reports;

application of criteria to evaluate the significance of non-conforming work;

remedial action taken, together with any decision about the acceptability of the non-conforming work;

notification of the customer, and if necessary, recall of work; and

responsibility for authorizing the resumption of work.

4.9.2 Follow-Up

If the non-conforming work could recur, or there are other significant problems identified, thecorrective action procedures in Volume I, Section 4.11 Corrective Action are promptly followed.

Related Procedures

Each ORA laboratory has a procedure for handling control of non-conforming work. Atemplate is provided. See Volume II, Section 1, ORA-LAB.4.9 Control of Non-

conforming Work.

4.10 Improvement

The effectiveness of the laboratorys management system is improved by using the followingactivities: internal audits; management reviews; analysis of quality control data; corrective

actions; preventive actions; the quality policy; and the quality objectives.

4.11 Corrective Action

4.11.1 General


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Each ORA laboratory has acorrective action procedurethat designates the authorities for

implementing corrective action when one of the following is identified:

non-conforming work,

departures from the policies and procedures in the management system, and

departures from required technical operations.

4.11.2 Cause Analysis

The procedure for corrective action includes investigating and determining the root cause of thenon-conformance.

4.11.3 Selection and Implementation of Corrective Actions

Potential corrective actions are identified. The action most likely to eliminate the problem and to

prevent recurrence is selected.

The corrective action chosen addresses the magnitude of the non-conformance and the risk

attributed to the non-conformance.

Corrective actions are documented, and any changes resulted from the corrective action

investigation are implemented.

4.11.4 Monitoring of Corrective Actions

The corrective action procedure addresses the monitoring for the effectiveness of correctiveactions performed.

4.11.5 Additional Audits

Where the identification of non-conformances or departures casts doubts on the laboratorys

conformance with management system policies and procedures or conformance with ISO/IEC

17025, the areas of activity affected by the non-conformance are audited as soon as possible inaccordance with Volume I, Section 4.14 Internal Audits.

Related Procedures

Each ORA laboratory has its own corrective action procedure. A template is provided.See Volume II, Section 1, ORA-LAB.4.11 Corrective Action.


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4.12 Preventive Action

4.12.1 General

Sources for needed improvements and potential sources of non-conformance are identified

according to the process described in the laboratorys preventive action procedure, and are part

of the management review process. Preventive actions plans are developed, implemented, andmonitored to address the identified opportunities for improvement.

4.12.2Procedure

The procedure includes the initiation of action. The management review process monitors the

effectiveness of such actions in providing improvement to the management system.

Related Procedures

Each ORA laboratory has a preventive action procedure. A template is provided. SeeVolume II, Section 1, ORA-LAB.4.12 Preventative Action.

Each ORA laboratory has a management review procedure. A template is provided. See

Volume II, Section 1, ORA-LAB.4.15, Management Review.

4.13 Control of Records

4.13.1 General

4.13.1.1 Procedure

Each ORA laboratory has a control of records procedure for identifying, collecting, indexing,

accessing, filing, storing, maintaining, and disposing of quality and technical records. Quality

records include reports from internal audits, management reviews, corrective actions, and

preventive actions.

4.13.1.2 Legibility, Storage, and RetentionRecords are to be legible. Laboratory reports (recorded on FDA form FD-431 and FDA form

FD-431a) are archived upon final review to the designated home district office for storage.

Laboratory reports can be retrieved by requesting the report from the designated home district

record management center. A record retention schedule is included in the laboratorys procedureor in the SMG 3291.2, Field Office Filing System.


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4.13.1.3 Security and Confidentially

Access is controlled in FDA facilities; only authorized personnel are allowed in the laboratory

and record management center. Records are stored in secured areas. Records are confidential and

redacted before release in accordance with Freedom of Information (FOI) process.

4.13.1.4 Electronic Records

Each ORA laboratory has a procedure describing the protection and back-up of electronic

records. The procedure also describes the safeguards in place to prevent unauthorized access toor amendment of electronic records.

4.13.2 Technical Records

4.13.2.1 Retained Records, Audit Trail, and Identification

Laboratory reports, depending on the type of analysis, include the original observations, derived

data, calculations, standard preparation, instrument printouts, and results. These reports are

retained until closed in FACTS and final review is performed. An electronic test report is inFACTS. Staff records, equipment calibration, and verification reports are retained in accordance

with the laboratorys control of records procedure.

The records contain sufficient information to establish an audit trail.

The records of each test contain sufficient information in order to repeat the test under conditionsas close as possible to the original. This information includes factors that affect uncertainty and

any environmental conditions that affect the test.

The collection report in FACTS identifies the personnel responsible for sampling. The FDA formFD-431a includes the identity of the personnel responsible for performance of each test and for

checking the results.

4.13.2.2 Recording and IdentificationObservations, data, and calculations are recorded at the time they are made and are identifiable to

the activity performed. Method numbers and titles are used to provide traceability of records toactivities.

4.13.2.3 Corrections


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When errors occur in records, each mistake is lined out, not erased, not made illegible, nor

deleted. The correct value is entered, initialed, and dated. In the case of records stored

electronically, equivalent measures are taken to avoid loss or change of original data.

Related Procedures

SMG 3291.2, Field Office Filing System

Food Drug and Cosmetic Act, Section 301(j)

18 United States Code (USC) 1905, The Trade Secrets Act

Each ORA laboratory has its control of records procedure. A template is provided. See

Volume II, Section 1, ORA-LAB.4.13 Record and Data Management.

4.14 Internal Audits

4.14.1 General

Internal audits are conducted according to a schedule included in the laboratorys audit

procedure. Internal audits are conducted of activities to verify that operations continue toconform to the requirements of the management system and ISO/IEC 17025.

The internal audit program addresses all elements of the management system, including testingactivities. The laboratorys Quality Management System Manager is responsible for the

coordination of internal audits as listedby the schedule and requested by management.

Trained and qualified personnel are responsible for conducting internal audits. Audits are

performed by personnel other than those who performed the work being audited.

4.14.2 Corrective Action

When audit findings cast doubt on the effectiveness of the operations or on the correctness or

validity of the laboratorys test results, corrective action is undertaken according to thelaboratorys corrective action procedure.

The customer is notified if investigations show that non-conformances related to audit resultsalso have affected work performed for the customer. This notification is documented.


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4.14.3 Audit Records

The area of activity audited, the audit findings, and corrective action that arise from them arerecorded according the laboratorys audit procedure

4.14.4 Follow-up Audit Activities

Follow-up audit activities are conducted to verify and record the implementation and

effectiveness of the corrective action taken. This follow-up is included as part of the

management review process.

Related Procedures

Each ORA laboratory has its own audit procedure. A template is provided. See VolumeII, Section 1, ORA-LAB.4.14 Audits

Volume II, Section 1, ORA-LAB.4.11 Corrective Action

4.15 Management Reviews

4.15.1 General

The laboratorys management review procedureincludes the schedule for conductingmanagement reviews. This review is conducted by the laboratorys executive management toensure continuing fitness for use and effectiveness of the management system and to introduce

needed changes or improvements.

The management review addresses the elements of the management system and includes but isnot limited to the following elements:

suitability of policies and procedures (Volume II, Section 1, ORA-LAB.4.2 Management

System); reports from managerial and supervisory personnel (Volume II, Section 1, ORA-

LAB.4.1 Organization;

outcome of recent internal audits (Volume II, Section 1, ORA-LAB.4.14 Audits);

corrective and preventive actions (Volume II, Section 1, ORA-LAB.4.11 CorrectiveAction Procedure, 4.11 Preventative Action Procedure);


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assessments by external bodies (Volume II, Section 1, ORA-LAB.4.14 Audits);

results of interlaboratory comparisons, proficiency test, and quality control (Volume II,Section 2, ORA-LAB.5.9 Assuring the Quality of Test Results);

changes in the volume and type of work (Volume II, Section 1, ORA-LAB.4.4 Requests,

Tenders and Contracts);

customer feedback (Volume II, Section 1, ORA-LAB.4.8 Complaints);

complaints (Volume II, Section 1, ORA-LAB.4.8 Complaints); and

other factors, such as quality control activities, resources (Volume II, Section 1, ORA-LAB.4.1 Organization) and staff training (Volume II, Section 2, ORA-LAB.5.2

Personnel: Training Procedure).

The findings and the actions that arise from the review are recorded according to the laboratorys

management reviewprocedure. Each action includes a target date for resolution.

Related Procedures

Each ORA laboratory has its own management review procedure. A template is provided.See Volume II, Section 1, ORA-LAB.4.15 Management Review.

5.0 Technical Requirements

5.1 General

The sections following below address the factors affecting the correctness and reliability of the

tests performed by a laboratory. These factors include contributions from:

personnel (Volume II, Section 2, ORA-LAB.5.2 Personnel: Training Procedure),

accommodation and environmental conditions (Volume II, Section 2, ORA-LAB.5.3Facilities and Environmental Conditions),


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test and calibration methods and method selection and validation (Volume II, Section 2,

ORA-LAB.5.4 Test Methods and Validation),

equipment selection and calibration (Volume II, Section I, ORA-LAB.4.6 Purchasing andReceipt; Section 2, ORA-LAB.5.5 Equipment),

measurement uncertainty and traceability (Volume II, Section 2, ORA-LAB.5.4 TestMethods and Validation; ORA-LAB.5.6 Measurement Traceability), and

handling of test and calibration items (Volume II, Section 2, ORA-LAB.5.8 Sample

Management).

The procedures listed in each section address these factors.

5.1.2 Contribution to Total Uncertainty of Measurement

These factors are considered in determining total measurement uncertainty and in developinguncertainty budgets. Additionally, these factors are considered by the laboratory when

developing test procedures, in the training and qualification of personnel, and in the selection of

the equipment utilized.

5.2 Personnel

5.2.1 Personnel Competence

Laboratory management ensures that laboratory personnel have the knowledge, skills, and

abilities to perform their duties. Competence is based on education, experience, demonstratedskills, and training. Staff records contain the documentation of personnel education, experience,

skills, and training for the position held.

Trainees undergo a training program in accordance with the laboratorys training procedure and

FDA Office of Resource Management/Division of Human Resource Development (DHRD)standards. For in-house training, a senior analyst serves as the trainer. Trainees perform

procedures when training is completed and competency has been demonstrated. Thedocumented demonstration of competence is an exercise that the trainee performs independent

of supervision. The trainee is considered competent after the specified criteria have been

successfully met.


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5.2.2.1Goals for Education, Training and Skills

The individual and management are jointly responsible for the setting, the pursuit, andachievement of educational goals for professional advancement. The annual performance

evaluation process can be used by the individual to discuss career advancement and training

possibilities. By using this process, individuals have the opportunity to identify areas of study

and request training oriented towards the attainment of their goals. Procedures for employeecareer development are described in SMG 3120.1, Staff Development and Training, and FDA

Supervisors Desk Reference, Chapter 8, Training and Development.

Training needs are identified by the analysts discipline (e.g. Chemist, Microbiologist) and FDAORM/DHRD standards. In-house training is conducted according to laboratorys training

procedure. Present and anticipated tasks of the laboratory are addressed in the planning of specialtraining modules.

Skills of personnel are based upon demonstration of competence. This demonstration is to becompletedsuccessfully before analysts generate data independently. The effectiveness of

personnel training is documented in but not limited to management reviews, internal audits,

external assessments, proficiency testing, and performance evaluations.

5.2.3 Employees and Contracted Personnel

The laboratory utilizes the skills and talent of both full-time employees and contract personnel.The requirements of the management system are administered equally to both categories. No

differentiation is made between the two categories of workers. Supervision, training, and

competence are documented forall technical and key support personnel.

5.2.4 Job Descriptions

The laboratory maintains activejob descriptions for managerial, technical, and key supportpersonnel involved in tests. Job descriptions are established based on current duties and

technologies utilized.

5.2.5 Management Authorization

The Laboratory Management authorizes identified personnel to:

perform testing and calibration,

issue test reports,


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give opinions and interpretations, and

operate particular types of equipment.

Records of authorizations, demonstration of competence, education, training, and experience are

maintained by the laboratory and dated. Training files are maintained and include these records.

Related Procedures

Volume II, Section 2, ORA-LAB.5.2 Personnel: Training Procedure

Each ORA laboratory maintains employee training files and authorizations.

5.3 Accommodation and Environmental Conditions

5.3.1 Facilities and Environmental Conditions

The laboratory environmental conditions facilitate the correct performance of analytical testing.Test methods used by the laboratory include instructions addressing applicable environmental

conditions. Examples of environmental influences are energy sources, lighting, biological

sterility, dust, humidity, and temperature. The laboratory monitors critical environmental

conditions to ensure that results and the quality of the measurement are not adversely affected orinvalidated.

In the event mobile labs are deployed, the laboratory is aware of and complies with all theenvironmental requirements and laws for the location. The technical needsfor accommodation

and environmental conditions that can affect the results of test are documented with the data

generated.

5.3.2 MonitoringEnvironmental conditions requiring monitoring include, but are not limited to:

room temperature and humidity,

air flow rates for chemical fume hoods,

biosafety hoods and laminar flow hoods,

metal contamination on benches and hoods in laboratories performing metal analysis,


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microbiological contamination on bench surfaces and hoods in microbiology

laboratories, and

air sampling for microbiological contamination in microbiology areas.

Where environmental controls are needed, the environmental conditions are recorded.

Testing activities are stopped when the environmental conditions invalidate the test results or adversely affect

quality control. Monitoring activities are conducted as part of the laboratory test or calibration methods.

5.3.3 Cross-contamination

Separate areas are maintained for incompatible activities. Measures taken to prevent cross-

contamination include but are not limited to:

chemistry laboratories are separated from microbiology laboratories,

sample receiving and storage are conducted in designated areas,

separate storage for standards and reference materials and cultures, and

microbiology media preparation and sterilization are separated from work areas.

5.3.4 Access

Laboratories are limited access areas. Access is controlled by but is not limited to:

issuance of keycards for entrance,

escorting visitors,

issuance of identification badges, and

the use of security guards.

5.3.5 Housekeeping

Laboratory areas are maintained clean and orderly to prevent contamination of samples and tofacilitate the efficiency of laboratory operations. Volume II, Section 2, ORA-LAB.5.3 Facilities

and Environmental Conditions specifies minimum housekeeping measures. The laboratorys

Chemical Hygiene Plan and Hazardous Waste Management Planinclude measures taken toensure good housekeeping in the laboratory.

Related Procedures


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Volume II, Section 2, ORA.LAB.5.3, Facilities and Environmental Conditions

Laboratory Chemical Hygiene Plan

Laboratory Waste Management Plan

5.4 Test Methods and Method Validation

5.4.1 General

The scope of test technologies and associated method source routinely used are identified in the

laboratorys accreditation program documentation.

The estimation of the uncertainty of measurementis addressed in Volume I, subsection 5.4.6.

and Volume I, Section 5.9 Assuring the Quality of Test Results of this manual describes thequality control processes, including the application of statistical techniques, for supporting test

and calibration data.

The laboratory instructions for the use and operation of equipment called for by the laboratorymethods is either a laboratory procedure identified on the master listor as equipment manuals.

Procedures for the handling of items for testing are addressed in Volume 1, Section 5.8 Handling

of Samples. Equipment manuals and standards forthe laboratorys scope of testing technologies

are controlled as external documents according to Volume I, Section 4.3 Document Control.Deviations from test methods are documented, technically justified, authorized, and where

circumstances call for it, accepted by the customer according to Volume II, Section 2, ORA-LAB.5.10 Reporting Laboratory Data, 6.D.

5.4.2 Selection of Methods

Standard methods are those published by international, regional or national standards-writing

bodies; by reputable technical organizations; in legal references; and FDA published methods.

FDA official methods are those in compendia specified in the FD&C Act and prescribed in theCFR and methods in applications and petitions that have official status are included. These

methods include those in the United States Pharmacopeia, National Formulary, HomeopathicPharmacopeia of the United States, Official Methods of Analysis of the Association of Official

Analytical Chemists (AOAC) International or any supplement of any of them, American Public

Health Association (APHA) Compendium of Methods for the Microbiological Examination ofFoods, FDA compliance programs, the Pesticide Analytical Manual (PAM), the Food Additives

Analytical Manual, the Food Chemicals Codex, FDA Bacteriological Analytical Manual (BAM),

FDA Macroanalytical Procedures Manual (MPM), and ORA Laboratory Information Bulletins(LIBs) that are included in compliance programs and special assignments. Standard methods are


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preferred for use and are verified for use in the laboratory. A standard method may be

supplemented with additional details in the form of a laboratory procedure to ensure consistent

application. Those methods specified by the manufacturer of the equipment are considered asstandard methods. Standard methods are verified according to the procedure, Volume II, Section

2, ORA-LAB.5.4.5 Methods, Method Verification and Validation.

Laboratory methods are selected to meet the customers need as addressed in Volume I, Section4.4 Review of Requests, Tenders and Contracts. The laboratory methods are controlled as

external documents according to Volume I, Section 4.3 Document Control.

When the customer does not specify the method to be used, a standard method is preferred foruse. If a standard method is not found the laboratory may use either a non-standard method or

modify a method for use with the concurrence of the customer. The non-standard or modifiedmethod is validated according to Volume I, subsection 5.4.5 Validation of Methods.

The laboratory informs the customer when the method proposed by the customer is considered tobe the incorrect choice or the incorrect revision for the intended purpose. This is done as part of

contract review addressed in Volume I, Section 4.4 Review of Requests, Tenders and Contracts.

5.4.3 Laboratory Developed Methods

If a laboratory develops methods for its own use, the laboratory has its own procedure for itsintroduction. This procedure provides the planned activities, identification of qualified personnel,and resources. Plans are revised as method development proceeds and effective communication

amongst all personnel involved is strongly encouraged. Laboratory developed methods adopted

by the laboratory are used if they are validated according to Volume I, subsection 5.4.5Validation of Methods.

5.4.4 Non-standard Methods

Non-standard methods are those methods not taken from authoritative, validated sources. A non-

standard method has not undergone validation, such as a collaborative study or process to

evaluate the methods performance capabilities.

Non-standard methods are selected for use when a customer request cannot be addressed with the

use of a standard method. Such methods are subject to agreement with the customer and a clearspecification of the customer's work requests, including the purpose of the test, is made. This

process is described for contract amendments in Volume I, subsection 4.4.5 Amendments to

Contracts with laboratory management concurrence. Non-standard methods are validated


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according to Volume I, subsection 5.4.5 Validation of Methods.

5.4.5 Validation of Methods

5.4.5.1 Definition

Validation is the confirmation by examination and the provision of objective evidence that theparticular specificationsfor an intended use are fulfilled.

5.4.5.2 Methods Requiring Validation

The laboratory validates non-standard methods, laboratory developed methods, and modified

standard methods including use outside the intended scope and applications. Validation isconducted to confirm that the methods are fit for the intended use. The validation is documented.

5.4.5.3 Process

The validation process addresses the needs of the given application or field of application. The

laboratory analyst records the results obtained according to the procedure, Volume II, Section 2,

ORA-LAB.5.4.5 Methods, Method Verification and Validation. The validation results include astatement as to whether the method is fit for the intended use. The needs of the customer define

the intended use of the method. The attributes and data quality objectives include but are notlimited to:

accuracy,

precision,

specificity,

detection limit,

limit of quantitation,

linearity,

range, and

ruggedness or robustness.

If all the data quality objectives are met as indicated by the data collected, the method is

considered as validated.

5.4.6 Estimation of Uncertainty of Measurement

5.4.6.1 Procedure for Calibration Activities


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ORA laboratories do not perform calibration activities. At such time that calibration activities are

performed, the ORA laboratories are to address the requirements of ISO/IEC 17025, 5.4.6.1.

5.4.6.2 Procedure for Testing Activities

The laboratory has a procedure, Volume II, Section 2, ORA-LAB.5.4.6, Estimation ofUncertainty of Measurement, to estimate the uncertainty of measurement for testing activities.

The application of details in cases where the nature of the test method may preclude rigorous,

metrologically and statistically valid, calculation of uncertainty of measurement is addressed inthe procedure.

An attempt is made to identify all the components of uncertainty and make a reasonable

estimation of the measurement uncertainty. This estimation is based on knowledge, experience,

and validation data of the performance of the method and on the measurement scope. If neededas a part of the laboratory data, the uncertainty estimation is reported according to the procedure,

Volume II, Section 2, ORA-LAB.5.4.6 Estimation of Uncertainty of Measurement.

5.4.6.3 Uncertainty Components

When estimating the uncertainty of measurement, all important uncertainty components arerecorded in the uncertainty records for each determination and test technology as addressed inthe procedure Volume II, Section 2, ORA-LAB.5.4.6, Estimation of Uncertainty of

Measurement.

5.4.7 Control of Data

5.4.7.1 Data Transfers

Calculations and data transfers are reviewed before the data is reported. All changes are

identified and verified where they occur. This process is detailed in the procedure forlaboratory

quality control identified in Volume I, Section 5.9 Assuring the Quality of Test Results.

5.4.7.2 Computer Use

When computers or automated equipment are used for the acquisition, processing, recording,

reporting, storage or retrieval of test data, the laboratory follows the process in the laboratorys

data protection procedure.


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5.4.7.2a. If computer software is developed by the user, its development is documented indetail and algorithms are validated.

5.4.7.2b. The laboratorys data protectionprocedure addresses the protection of the data toinclude, but not limited to data integrity, data confidentiality during entry, collection,

storage, transmission and processing.

5.4.7.2 c. Computers and automated equipment are maintained to ensure proper functioning and

are provided with the environmental and operating conditions to maintain the

integrity of test and data.

Related Procedures

Volume II, Section 2, ORA-LAB.5.4.5 Validation of Methods

Volume II, Section 2, ORA-LAB.5.4.6 Estimation of Uncertainty of Measurement

Each ORA laboratory has its own data protection procedure.

5.5 Equipment

5.5.1 Laboratory Equipment

The laboratory has sample preparation, measurement and test equipment for the correctperformance of the tests and calibrations. The laboratory also has ancillary equipment for

processing samples and for processing data.

The laboratory purchases the equipment used by the laboratory. Maintenance contracts are

established as needed. In those cases where the laboratory leases equipment it has direct control

concerning its use. Leased equipment is managed in the same manner as purchased equipmentaccording to the management system requirements.

ORA laboratories maintain an equipment inventory of all laboratory equipment used to perform

regulatory testing.

5.5.2 Equipment Capability

Equipment and its software used for testing is to achieve the accuracy expected and comply with

specifications of the testing concerned. Laboratory equipment that has a significant effect on the

results has a calibration schedule. The equipment performance is verified and verification


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records are maintained. Equipment is to meet the laboratory's testing parametersand conform to

standard specifications before being placed into service.

5.5.3 Authorized Operation

Personnel are authorized to operate equipment according to Volume I, subsection 5.2.5

Management Authorization. Authorization is based on work assignment, training, experience anddemonstrated proficiency. Equipment manuals and maintenance procedures are maintained and

supplied to laboratory personnel as described in Volume I, subsection 4.3.1 General and Volume

II, Section 2, ORA-LAB.5.5.1 Instrument and Equipment Documentation and Records.

5.5.4 Equipment Identification

Each item of equipment used for testing has an FDA property number or an identification

number that is unique to each instrument.

5.5.5 Equipment Records

Records are maintained of each item of equipment and its software significant to the tests or

calibrations performed according to the procedurein Volume II,Section 2,ORA-LAB.5.5.1Instrument and Equipment Documentation and Records.

The records include at least the following items:

identity of the item of equipment and its software;

manufacturers name, type identification, and serial number or other unique

identification;

performance checks that equipment conforms to testing parametersand acceptancecriteria;

location of the equipment;

manufacturers instructions;

dates, results and copies of reports and certificates of calibrations, adjustments,

acceptance criteria, and the due date of next calibration;


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maintenance plan and maintenance carried out to date; and

any damage, malfunction, modification or repair to the equipment.

5.5.6 Management of Equipment

The laboratory has a procedure in Volume II, Section 2, ORA-LAB.5.5 Equipment for the safe

handling, transport, storage, use and planned maintenance of measuring equipment to ensure

proper functioning and to prevent contamination or deterioration.

5.5.7.1 Out of Service

Equipment that has been subjected to overloading or mishandling, gives suspect results, or hasbeen shown to be defective or outside specified limits, is taken out of service. It is isolated to

prevent its use or clearly labeled or marked as being Out of Service to prevent its use until it

has been repaired and shown by calibration or test to perform correctly.

5.5.7.2 Retesting and Calibration

Laboratory personnel examine the effect of quality control analyses that indicate the defect or

departure from specified limits on previous tests according to Volume I, Section 4.9 Control of

Non-conforming Work.

5.5.8 Calibration Status

Equipment under the control of the laboratory and requiring calibration is labeled or coded toindicate the calibration status, including the date when last calibrated and the date due for

recalibration. Alternatively, equipment calibration status may be identified in an associated

record to indicate the status of calibration.

5.5.9 Equipment Leaving the Laboratory

If for any reason equipment leaves the direct control of the laboratory, the function andcalibration status of the equipment is checked upon return and shown to be satisfactory beforethe equipment is returned to service.

5.5.10 Calibration Confirmation


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Intermediate calibration confirmation checks are performed to maintain confidence in the

calibration status of the equipment. These checks are conducted according to the procedure in

Volume I, Section 5.9 Assuring the Quality of Test Results.

5.5.1.1 Correction Factors

Where calibrations give rise to a set of correction factors, these factors are communicated tousers.5.5.12 Safeguards

Test and calibration equipment, including both hardware and software, are safeguarded from

adjustments that would invalidate the test or calibration results. Safeguards are provided usingaccess control to the laboratory.

Related Procedures

Volume II, Section 2, ORA-LAB.5.5 Equipment

Volume II, Section 2, ORA-LAB.5.5.1 Instrument and Equipment Documentation and

Records

Each ORA laboratory has established equipment maintenance schedules in accordancewith the ORA system.

5.6 Measurement Traceability

5.6.1 General

The laboratory equipment is calibrated before being placed into service, as scheduledandfollowing repairs. Procedures for equipment calibration are provided in Volume II, Section 2,

ORA-LAB.5.5 Equipment.

5.6.2 Specific Requirements

5.6.2.1 Calibration Requirements for Contracting Metrologists

5.6.2.1.1 Measurement Traceability


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The program for calibration of equipment demandsthat calibrations and measurements made by

the laboratory are traceable to the International System of Units. The scheduling of calibration

activities is defined in Volume II, Section 2, ORA-LAB.5.5 Equipment, Table 2.

Contracting metrologists providing services to ORA laboratories are to provide evidence of

measurement traceability of its own measurement standards and measuring instrument to the SI.

This is done by means of an unbroken chain of calibration or comparisons linking them toprimary standards of the SI units of measurement. Such primary standards are those used by

national measurement standards.

The measurement traceability to SI units may be achieved by measurements related to nationalmeasurement standards. National measurement standards may be used as primary standards that

are primary realizations of the SI units or agreed representations of SI units. Nationalmeasurement standards based on fundamental physical constants, or standards calibrated by

another national metrological institute may be use as primary standards.

Contracting metrologists providing services to ORA laboratories are to provide documentation

demonstrating measurement capability and competence to perform the calibration services

requested by ORA laboratories.

Calibration certificates issued by contracting metrologists are to include the measurement results,

including the measurement uncertainty and a statement of conformance with an identifiedmetrological specification.

5.6.2.1.2.1 Non-traceability of reference standards to SI units

Calibrations that cannot provide strict measurement traceability to SI units areconducted such

that the calibration results can provide confidence in the measurements made in the course of the

analyses. Traceability alternatives to SI units are described in the procedure in Volume II,

Section 2, ORA-LAB.5.6 Measurement Traceability.

5.6.2.1.2.2 Interlaboratory comparisons

ORA laboratories participate in FDAs National Check Sample Program, the AOAC Standard

Microbiology Proficiency Testing Program, and other national or international proficiency

programs, as applicable.

5.6.2.2 Testing


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5.6.2.2.1 Testing and calibration activities

The requirements of Volume I, Subsection 5.6.2.1 Calibration-Requirements for ContractingMetrologists are included in the laboratorys calibration program for equipment that has a

significant contribution from its calibration to the total measurement uncertainty. Contributions

are considered significant if they are greater than a fifth of the largest contributor.

The measurement of uncertainty is determined and recorded according to Volume II, Section 2,

ORA-LAB.5.4.6, Estimation of Uncertainty of Measurement.

Equipment that does not contribute appreciably to the total uncertainty of the test result isexempt from the activities described in Volume I, Subsection 5.6.2.1 Calibration-Requirements

for Contracting Metrologists.

5.6.2.2.2Non-traceability to SI Units

Where measurement traceability for testing and calibration activities to SI units is not possible,

the policies stated in Volume I, subsection 5.6.2.1 Calibration-Requirements for Contracting

Metrologists are followed.

5.6.3 Reference Standards and Reference Materials

5.6.3.1 Reference Standards

The laboratory calibrates its reference standards. Details are included in Volume II, Section 2,

ORA-LAB.5.5 Equipment.

A contracting metrologist who is to provide measurement traceability as described in Volume I,

subsection 5.6.2.1 calibrates the reference standards.

The reference standards are used for calibration only.

5.6.3.2 Reference Materials

A reference material is a homogenous and well characterized substance used for standardization

of equipment used in the testing process. Reference materials are traceable to national orinternational standard reference materials (SRMs), such as National Institute of Standards and

Technology (NIST), or certified reference materials (CRMs) from competent suppliers of

reference materials.


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